Isoproterenol Hydrochloride Injection, Solution
NDC Package 83634-303-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Isoproterenol Hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia. This formulation utilizes a injection, solution delivery system. Marketed by Avenacy, Inc., this product is identified by NDC 83634-303 and is authorized under FDA application ANDA212189.

Identification & Billing

NDC Package Code
83634-303-01
Package Description
10 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (83634-303-41)
Product Code
83634-303
11-Digit Billing Format
83634030301
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Isoproterenol Hydrochloride
Non-Proprietary Name
Isoproterenol Hydrochloride
Substance Name
Isoproterenol Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
ISOPROTERENOL HYDROCHLORIDE .2 mg/mL
Pharmacologic Class
Usage Information
Isoproterenol hydrochloride injection is indicated: To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output For bronchospasm occurring during anesthesia

Regulatory & Marketing

Labeler Name
Avenacy, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212189
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-15-2024
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (83634-303). Click a package code to view its specific billing and regulatory data.

83634-303-05
10 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE (83634-303-42)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83634-303-01 identifies a specific commercial package of 10 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (83634-303-41) of Isoproterenol Hydrochloride, a human prescription drug labeled by Avenacy, Inc.. This injection, solution is formulated for intravenous use and contains isoproterenol hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Avenacy, Inc. on May 15, 2024. The current certification is valid through December 31, 2026.

How is this Avenacy, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83634030301. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83634-303-01
11-Digit CMS (5-4-2)
83634-0303-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.